FDA 510(k), K182983, iFuse Implant System®

FDA 510(k), K182983, iFuse Implant System®

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510(K) Number: K182983
Device Name: iFuse Implant System®
Manufacturer: SI-BONE, Inc.
Device Classification Name: sacroiliac joint fixation
Regulation Number: 888.3040
Classification Product Code: OUR
Date Received: 10/29/2018
Decision Date: 11/27/2018
Regulation Medical Specialty: Orthopedic

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